By Charles Craig

Texas Biotechnology Inc., which expects to file a new drug application (NDA) by the end of this quarter for Novastan, said its lead drug, under development as a heparin substitute, succeeded as an effective anticoagulant when used in patients undergoing acute coronary intervention, such as angioplasty.

The Phase III trial was conducted in 30 patients with a history of heparin-induced thrombocytopenia (HIT), meaning they were allergic to heparin, the standard anticoagulant therapy.

David McWilliams, president and CEO of Texas Biotechnology, said the trial was a supplemental study to the Houston company's ongoing 300-patient Phase III trial of Novastan for use in non-interventional treatments with patients allergic to heparin. Such treatments, he said, would include post-operative therapy to prevent blood clots and treatment of deep vein thrombosis.

Data from both trials will be submitted to the FDA, McWilliams said, but the company anticipates initially seeking approval of Novastan for patients allergic to heparin during non-interventional procedures. Results from the 300-patient Phase III trial are expected soon and will be discussed in June at a Florence, Italy, conference of the International Society of Thrombosis and Hemostasis.

McWilliams said the company expects to submit its NDA for Novastan by the end of the second quarter, "give or take a few weeks."

In the 30-patient Phase III study, Novastan met its primary endpoint of enabling all subjects to complete their treatments, which included angioplasty and stent placement.

McWilliams also noted only one of the 30 patients experienced bleeding complications, which is a side effect of heparin that occurs in almost 10 percent of patients.

He said previous clinical trials of Novastan have shown bleeding complications were a problem about two percent of the time.

In addition to evaluating Novastan for use in patients allergic to heparin, Texas Biotechnology is testing its drug in head-to-head trials for broader use as a more effective alternative to heparin in combination with thrombolytics to treat acute heart attacks.

Novastan (argatroban) is a small-molecule inhibitor of thrombin, an enzyme involved in blood clotting.

Texas Biotechnology's stock (AMEX:TXB) closed Thursday at $4.50, unchanged. *